4'-ethoxy-3-hydroxy-2-naphthanilide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: performed in accordance with OECD and GLP guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4'-ethoxy-3-hydroxy-2-naphthanilide

EC Number:

225-200-7

EC Name:

4'-ethoxy-3-hydroxy-2-naphthanilide

Cas Number:

4711-68-6

Molecular formula:

C19H17NO3

IUPAC Name:

N-(4-ethoxyphenyl)-3-hydroxy-2-naphthamide

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9-mix

Test concentrations with justification for top dose:

1st + 2nd experiment: 4 - 5000 µg/plate

Vehicle / solvent:

Tested substance suspended in aqua bidest.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (TA100, TA1535), 9-aminoacridine (TA1537), 2-nitrofluorene (TA98)

Remarks:

without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (all strains)

Remarks:

with metabolic activation

Details on test system and experimental conditions:

Method of application:
in agar (plate incorporation assay)
duration of incubation: approximatelyt 48h at 37°C in the dark

Determination of cytotoxicity:
Method:
1. experiment: reduction of spontaneous revertants or clearing of the bactarial background lawn
2. experiment: surving fraction (comparision of number of colonies between plates of solvent control and substance)

Evaluation criteria:

Increase of revertant colonies

Statistics:

Number of colonies per plate for each strain as well as mean values of the colonies of 3 plates/dose were counted.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Visible precipitation of the test compound was observed in the 1st and 2nd experiment at 100 µg/plate and above.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation

The test substance was not mutagenic in the presence and absence of a metabolizing system in this tested Salmonella typhimurium reverse mutation assay.

Executive summary:

Naphtol AS-VL was tested for mutagenicity with the strains TA 100, TA1535, TA 1537, TA 98 of Salmonella typhimurium.

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different doses from 4 to 5000 µg/plate (1st and 2nd exp.) was used.

Toxicity: The tested compound was proved to be not toxic to the bacterial strains with and without metabolic activation.

Mutagenicity: In the absence and in the presence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains.

It can be stated that the tested sample of Naphtol AS-VL is not mutagenic in these bacterial test systems without and with exogenous metabolic activation at the dose levels investigated.